(252 days)
The IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.
IV Administration Sets are single use, disposable, intravenous administration sets used to deliver fluids from a container into a patient's vascular system. These sets may be comprised of various components which are broadly used throughout industry including insertion spike, drip chamber, clamp, luer access device, check valve, stopcock, manifold, tubing, luer connections (connector, adaptor), and filter. IV Administration sets are configured to ensure the intended use of the device is met. The proposed device, IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system.
The provided text describes a 510(k) premarket notification for "IV Administration Sets" by B. Braun Medical Inc. It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving that the device meets specific acceptance criteria in the manner of an AI/algorithm-based device.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable to this type of regulatory submission, as it's for a physical medical device (IV administration sets), not an AI/ML algorithm.
However, I can extract information related to acceptance criteria (performance standards) and the "study" (non-clinical performance testing) used to demonstrate adherence to these criteria.
Here's the information formatted as requested, with "N/A" for inapplicable fields:
Acceptance Criteria and Device Performance for IV Administration Sets (K170595)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Standard) | Test Conducted | Reported Device Performance (Conclusion) |
|---|---|---|
| ISO 594-1:1986 | Luer Compliance | Results of testing show that the proposed devices meet the same performance specifications as the predicate device. |
| ISO 594-2:1998 | Luer Compliance | Results of testing show that the proposed devices meet the same performance specifications as the predicate device. |
| ISO 8536-4:2010/Amd. 1: 2013 | Flow Rate, Positive Pressure, Negative Pressure, Static Tensile | Results of testing show that the proposed devices meet the same performance specifications as the predicate device. |
| ISO 10993-1:2009 | Cytotoxicity | Materials meet biocompatibility requirements per ISO 10993-1. |
| Sensitization | Materials meet biocompatibility requirements per ISO 10993-1. | |
| Intracutaneous Reactivity | Materials meet biocompatibility requirements per ISO 10993-1. | |
| Systemic Toxicity | Materials meet biocompatibility requirements per ISO 10993-1. | |
| Hemolysis | Materials meet biocompatibility requirements per ISO 10993-1. | |
| Material Mediated Rabbit Pyrogen | Materials meet biocompatibility requirements per ISO 10993-1. | |
| Characterization of Leachables | Materials meet biocompatibility requirements per ISO 10993-1. | |
| Additional Tests | Dynamic Tensile | Results of testing show that the proposed devices meet the same performance specifications as the predicate device. |
| Priming | Results of testing show that the proposed devices meet the same performance specifications as the predicate device. Also, Air Bubble Visualization. | |
| Air Bubble Visualization | Results of testing show that the proposed devices meet the same performance specifications as the predicate device. | |
| Low Pressure Occlusion | Results of testing show that the proposed devices meet the same performance specifications as the predicate device. |
Details of the "Study" (Non-Clinical Performance Testing)
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Sample size used for the test set and the data provenance: Not explicitly stated how many individual IV sets were tested for each performance test. The data provenance is from "nonclinical performance testing" performed by B. Braun Medical Inc. (manufacturer), as part of a 510(k) submission to the FDA. This is considered prospective testing for regulatory submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth for physical device testing is typically based on objective measurements against established technical standards, not expert consensus in the diagnostic sense.
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Adjudication method for the test set: N/A. Testing is based on objective measurement against defined pass/fail criteria from international standards.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A. This is not an AI/ML device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This is not an AI/ML device.
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The type of ground truth used: The "ground truth" for this device's performance is adherence to the specified international performance standards (e.g., ISO 594-1, ISO 8536-4) and biocompatibility standards (ISO 10993-1). This involves objective measurement of physical and material properties.
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The sample size for the training set: N/A. This is not an AI/ML device.
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How the ground truth for the training set was established: N/A. This is not an AI/ML device.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.